Status:

COMPLETED

Patient Activation Through Counseling, Exercise and Mobilization

Lead Sponsor:

Herlev and Gentofte Hospital

Collaborating Sponsors:

Rigshospitalet, Denmark

University of Copenhagen

Conditions:

Pancreas Cancer

Biliary Tract Cancer

Eligibility:

All Genders

65+ years

Phase:

NA

Brief Summary

PACE-Mobil-PBL is a prospective randomized controlled trial. The aim is to investigate the effect of a multimodal and exercise-based intervention among older patients with advanced pancreatic cancer, ...

Eligibility Criteria

Inclusion

  • Inclusion Criteria, participants must:
  • Be diagnosed with locally advanced or metastatic pancreatic cancer, OR locally advanced or metastatic biliary tract cancer, OR locally advanced or metastatic non-small cell lung cancer within 12 weeks.
  • Have unresectable cancer.
  • Be treated with first-line palliative chemotherapy, immunotherapy or targeted therapy at the Department of Oncology, Herlev and Gentofte Hospital.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
  • Have the ability to speak and read Danish, and to provide a signed informed consent form.
  • Exclusion Criteria, patients with:
  • Small-cell lung cancer.
  • Any physical condition that hinder the execution of physical exercise training.
  • Documented and uncontrolled brain metastases that hinder participation in an exercise-based trial, based on the referring oncologist's assessment.
  • Dementia, psychotic disorders, or other cognitive diseases or conditions that hinder participation in a clinical exercise-based trial.
  • Unstable medical disease or history of serious or concurrent illness; any Medical condition that might be aggravated by exercise training or that cannot be controlled, including, but not restricted to congestive heart failure (NYHA class II-IV), unstable angina pectoris, implantable cardioverter defibrillator, or myocardial infarction within 6 months, based on the referring oncologist's assessment.
  • In patients with bone metastases:
  • \- A bone metastatic burden or location that poses a risk of injury in the performance of exercise training, as assessed by the referring oncologist.

Exclusion

    Key Trial Info

    Start Date :

    April 4 2018

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 1 2020

    Estimated Enrollment :

    99 Patients enrolled

    Trial Details

    Trial ID

    NCT03411200

    Start Date

    April 4 2018

    End Date

    July 1 2020

    Last Update

    July 14 2020

    Active Locations (1)

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    Herlev and Gentofte Hospital, Department of Oncology

    Herlev, Denmark, 2730